The purpose of this position is to supervise and maintain the manufacturing operations in Julphar XII sterile fill finish facility as per the cGMP norms and respective guidelines.
Key responsibilities & Accountability:
Premises check and follow up:
Material Follow up & Personnel follow up.
Environments monitoring Parameters.
Equipment check Follow up:
Calibration &preventive Maintenance in accordance with GMP principles.
Receiving and reviewing raw and primary Packaging Materials
Material Preparation, CIP & SIP: formulation tank, Mobile tanks, Sterile filling tanks, Washing and Sterilization of cartridges, plunger stoppers and combi-seals, Filtration, Filling Machine Parts.
Processing: Dispensing raw materials, Formulation, Material preparation, Filtration, Filling, Inspection, Labeling, and Shipment in accordance with GMP Principle.
Manufacturing methods MFM , process flow charts, process description and in-process control check tests.
Review all calculations related to the manufacturing process and material requisitions
Documentation: on line updation and maintaining the GMP documents in accordance with the regulatory requirement.
Handling of SAP processes
Coordination with the Engineering department for all Engineering work: HVAC, Water system, Validation.
Candidates with minimum qualification of Bachelor of Pharmacy or life science can apply.
The ideal candidate should have minimum experience of 3-4 years in sterile injectable manufacturing.
Able to lead a team, work independently and work in shifts.
Must be able to understand Basic English and communicate properly.
Must understand the processes and adhere to it efficiently.